News / January 11, 2022
Over the past year there has been a lot of increased emphasis and attention placed on pre-cleaning surgical instruments at the point of use prior to transport to sterile reprocessing. This new, increased emphasis on pre-cleaning is important to you, your facility and most importantly, to your patients and their safety.
A recent post on the Association for the Advancement of Medical Instrumentation (AAMI) members’ discussion board from an O.R. supervisor stated “We recently had a Joint Commission survey. We were told that instruments need to be cleaned at the point of use prior to going to SPD. We have always wiped instruments off and covered them with an enzymatic cleaner. Now, after a consultant was here, we are placing instruments in sterile water and cleaning all bioburden from them prior to placing them in an enzymatic cleaner for transport to SPD.”
So what has led to all of this increased emphasis on surgical instrument pre-cleaning? It is coming from several different sources and organizations. A quick review of those sources and organizations will help explain the new emphasis on pre-cleaning, what is driving it and why it is important for your patients’ safety.
The FDA is responsible for approving reusable medical devices through the 510(k) approval process. Part of the FDA’s approval process for new devices includes ensuring that the devices are safe for use in the healthcare environment and that the instructions for use (IFUs) have been validated by independent laboratory testing. The FDA is also responsible for monitoring the device manufacturers to ensure the safety and efficacy of their reusable medical devices after they’ve been approved and are in use in the market.
The Centers for Medicare and Medicaid Services (CMS) is responsible for the quality and safety of healthcare delivered by hospitals and healthcare facilities. As part of their responsibility, CMS authorizes various organizations such as the Joint Commission to ensure that hospitals and healthcare facilities comply with all of the various rules and regulations governing the safe operation of those facilities. Currently, the Joint Commission accredits and certifies nearly 21,000 health care organizations and programs in the United States.1
When it comes to standards, the American National Standards Institute (ANSI) is the organization that produces and publishes all standards for the United States. According to their website “The American National Standards Institute is a private non-profit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States.”2
AAMI submits their recommendations and documents for medical devices to ANSI to become the national standard for those devices. The Association of periOperative Registered Nurses (AORN) analyzes and interprets the AAMI standards for actual use and practice in the operating room environment. Joint Commission then conducts their surveys/audits based on the standards that have been set for sterile processing activities.
Section 7.3 of AAMI’s ST 79 addresses a medical device manufacturer’s responsibilities when it comes to decontaminating and cleaning their devices. Specifically, the manufacture must provide IFUs for the cleaning of the device utilizing methods and equipment available in any healthcare facility.3 The AORN’s “Guideline for Cleaning and Care of Surgical Instruments” identifies actions that must be taken by perioperative personnel to comply with AAMI ST 79.
Recommendation III in the AORN guideline states that instruments should be clean and decontaminated as soon as possible after use. Section III(a) discusses the need for cleaning instruments at the point of use as soon as possible. The goal of cleaning at the point of use is the removal of all gross bioburden. Then instruments are to remain moist (either from a water-soaked towel, enzymatic treatment or other method to maintain humid conditions) to prevent them from drying.4
The standard goes on to state that instruments should be cleaned during the surgical procedure and be kept free of gross soil. The surgical tech should clean the instrument using a sponge and sterile water as soon as the surgeon is done with the instrument. Instruments with lumens should be flushed with sterile water during the case to remove gross soil that remains trapped within the lumen. Additionally, all instruments on a sterile field are to be considered contaminated, regardless of whether or not they were touched, much less used.5
The AORN guidelines follow AAMI’s ST 79 recommendations almost verbatim. Specifically, Section 6.3 of ST 79 discusses in detail the ‘point of use’ care and handling of surgical instruments. Section 6.3.1 requires that instruments be wiped down to remove gross soil and that instruments with lumens be flushed periodically with sterile water throughout the procedure. Section 6.3.3 states that all instruments that are opened in the O.R. during a case are to be considered contaminated, whether used or not.6
These new recommendations and guidelines for point of use instrument cleaning will mean a process change in the O.R. at many facilities in order to comply with the Joint Commission’s new requirements. If however, the tech gets in the habit of cleaning instruments as the surgeon hands them back during the case, then cleaning at the end of the procedure will be significantly easier and the time required for cleaning will also be reduced. More importantly, the risk of a contaminated instrument getting through the entire reprocessing cycle will be reduced as well.
1 The Joint Commission website www.jointcommission.org
2 ANSI website www.ansi.org
3 AAMI ST 79, 2017
4 AORN’s “Guideline for Cleaning and Care of Surgical Instruments” Section III(a)
5 Op Cite
6 AAMI ST 79, 2017
Elmed Incorporated is an American* manufacturer and distributor providing the medical industry and its many specialties with quality products.
Elmed Incorporated is a wholly owned American company and is not associated with any other “Elmed” company based outside the United States.